Table 3.
GRADE evidence profile question 3: what is the effect of naltrexone–bupropion (N‐B) on the frequency of serious adverse events in overweight and obese subjects?
| Quality assessment | No of patients | Effect | Quality | Comments | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | N‐B | Placebo | Relative (95% CI) | Absolute | ||
| Overall rates of serious adverse events | ||||||||||||
| 4 | Randomised trials | seriousa | No serious inconsistency | No serious indirectness | No serious imprecision | None | 375/3088 (12.1%) | 101/1448 (7%) | RR 1.70 (1.38 to 2.1) | 49 more per 1000 (from 27 more to 77 more) | ⊕ ⊕ ⊕Ο MODERATE | NNTH 21 (13 to 38) |
| Serious (severe) adverse events reported as related or possibly related to intervention | ||||||||||||
| 4 | Randomised trials | seriousa | No serious inconsistency | seriousb | No serious imprecision | Very strong associationc | 260/3088 (8.4%) | 19/1448 (1.3%) | RR 5.72 (3.09 to 10.58) | 62 more per 1000 (from 27 more to 126 more) | ⊕ ⊕ ⊕ ⊕ HIGH | NNTH 16 (8 to 37) |
Settings: Academic and primary care centres; academic medical centres; private or institutional practices; research centres
a
High drop‐out rates; several investigators have financial ties to the study sponsor;
b
wide confidence interval;
c
RR >5.
CI: confidence interval; NNTH: number needed to treat to harm; RR: risk ratio